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Peri-procedural stress is a common challenge in interventional radiology that can negatively impact patient tolerance and the overall procedural experience. This randomized controlled trial (RCT) was designed to evaluate the clinical impact of a non-commercially available, newly-developed structured auditory neuromodulation system, designed to optimize patient experience during endovascular procedures for dysfunctional dialysis access.
Following an extensive development phase, a two-center RCT will be conducted at two Interventional Radiology Departments of tertiary university hospitals. Patients fulfilling the study's inclusion criteria will be randomized on a 1:1 basis to undergo endovascular procedures for dysfunctional dialysis vascular access-performed under local anaesthesia without sedation-either with the audio system (Group Sound; S) or without it (Group Control; C). The intervention is utilizing an MP3 audio system and headphones delivering binaural beats, isochronic tones, and music designed to induce relaxation by achieving the alpha brainwave state (8-12Hz). Patient experience will be evaluated via standardized self-reported questionnaires. Patient's demographical data and procedural details will be recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group Sound | Active Comparator | Patients randomized to undergo the procedure with the audio system |
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| Group Control | No Intervention | Patients randomized to undergo the procedure without the audio system |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neuromodulation auditory system | Device | An MP3 audio system delivering via headphones, binaural beats, isochronic tones, and music designed to induce relaxation by achieving the alpha brainwave state (8-12Hz). |
| Measure | Description | Time Frame |
|---|---|---|
| Overall patient experience | Completion of a standardized self-reported Stress-orientated questionnaire, with higher values indicating worst outcome. | Within the first hour after the procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stavros Spiliopoulos, MD, PhD | ATTIKO University General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| "ATTIKON" University General Hospital, , 1st Rimini St, | Athens | Select A State | 12461 | Greece | ||
| Patras University Hospital |
Upon reasonable request
After publication
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Randomized controlled trial
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| Pátrai |
| Greece |